Comparing metformin addition to standard care after bariatric surgery for diabetes remission
Extending Time Without Diabetes After Bariatric Surgery: a Randomized Controlled Trial Comparing the Metformin Addition or Not to Standard Care
This study is testing if adding metformin to regular care can help adults who had weight loss surgery keep their diabetes in remission longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 16 sites (Amiens and 15 other locations) |
| Trial ID | NCT04581447 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled, open-labeled, multicenter trial evaluates whether adding metformin to standard care can extend the duration of diabetes remission in adults who have undergone bariatric surgery. Participants will be adults aged 18-70 who had gastric bypass or sleeve gastrectomy 12 to 36 months prior and have achieved an HbA1c of less than 6.5% without anti-hyperglycemic medications. The study aims to address the significant number of patients who experience a return of diabetes after surgery, as current interventions to prolong remission have not been explored. By comparing outcomes between those receiving metformin and those receiving standard care, the trial seeks to provide insights into effective post-surgical diabetes management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 who have undergone gastric bypass or sleeve gastrectomy within the last 12 to 36 months and have achieved an HbA1c of less than 6.5%.
Not a fit: Patients with type 1 diabetes, those who are pregnant or breastfeeding, and individuals with contraindications to metformin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help prolong the duration of diabetes remission in patients after bariatric surgery, improving their overall health and quality of life.
How similar studies have performed: While bariatric surgery has shown favorable effects on diabetes remission, no prior studies have specifically tested the addition of metformin to extend this remission, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 18-70 years old * Having undergone gastric bypass or sleeve gastrectomy 12 to 36 +/-3 months before inclusion * "ex-T2D" treated with at least one anti-diabetic drug before bariatric surgery or HbA1c ≥ 6.5 % before bariatric surgery * HbA1C \< 6.5 % at inclusion with no anti-hyperglycemic medications for the last three months * Written consent Exclusion Criteria: * Known type 1 diabetes * Pregnancy and breastfeeding * Estimated glomerular filtration rate\<44 ml/min (MDRD) * Known intolerance to metformin * Known contraindication to metformin: * Acute metabolic acidosis * Acute affection which could lead to renal deterioration (ex: dehydration, serious infection, shock, intravascular administration of iodinated contrast agent within the last 48 hours) * Acute or chronic disease which could lead to a tissue hypoxia (ex : severe cardiac insufficiency, severe respiratory insufficiency, myocardial infarction within the last 3 months, shock) * Hepatocellular insufficiency * Prothrombin ratio ≤ 50% * SGOT or SGPT levels ≥ 10 times the upper limits of the normal range * Alcohol use disorder * Medications and medical conditions likely to confound the assessment of diabetes: * glucocorticoids treatment * renal graft * Cushing's syndrome * acromegaly * fasting plasma triglyceride \> 600 mg/dl despite treatment * Patient under legal protection
Where this trial is running
Amiens and 15 other locations
- CHU Amiens-Picardie - hôpital Nord — Amiens, France (Recruiting)
- AP-HP - hôpital Avicenne — Bobigny, France (Withdrawn)
- CHU de Bordeaux - hôpital Haut-Lévêque — Bordeaux, France (Recruiting)
- AP-HP - hôpital Ambroise-Paré — Boulogne-Billancourt, France (Recruiting)
- AP-HP - hôpital Louis-Mourier — Colombes, France (Recruiting)
- Centre hospitalier intercommunal de Créteil — Créteil, France (Recruiting)
- CHU de Lille - hôpital Claude Huriez — Lille, France (Recruiting)
- AP-HM - hôpital de la Conception — Marseille, France (Recruiting)
- AP-HM - hôpital Nord — Marseille, France (Withdrawn)
- AP-HP - hôpital européen Georges-Pompidou — Paris, France (Recruiting)
- AP-HP - hôpital Bichat-Claude Bernard — Paris, France (Recruiting)
- AP-HP - hôpital de la Pitié-Salpêtrière — Paris, France (Recruiting)
- Institut Mutualiste Montsouris — Paris, France (Recruiting)
- HCL - centre hospitalier Lyon-Sud — Pierre-Bénite, France (Recruiting)
- CH de Saint-Denis - hôpital Delafontaire — Saint-Denis, France (Not_yet_recruiting)
- CHU de Toulouse - hôpital Larrey — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Claire CARETTE, MD — claire.carette@aphp.fr
- Study coordinator: Aurélie GUIMFACK
- Email: aurelie.guimfack@aphp.fr
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.